Liability or life-saving: The risks associated with IVDs in personalised medicine

Over the past 10 to 15 years, there has been a steady trend towards personalised medicine, particularly in the field of oncology. This has led to increased use of in vitro diagnostic products, or investigational IVDs, to determine the right medicine for the patient. It is worth noting that personalised medicine is not a new […]

It’s a new, more costly world for medical devices – preparation is key!

The medical devices and in vitro diagnostics world has changed significantly under much tighter regulations. One standout example is the Medical Devices Regulation (MDR), which was adopted by the European Parliament and the Council in 2017. The Regulation states that medical devices can be placed on the EU market under CE certifications issued until 26 […]